A single-blind, placebo controlled, randomised study to evaluate antiviral activity and safety and pharmacokinetics of inhaled PC786 against respiratory syncytial virus (RSV) in healthy adult subjects in a virus challenge model

Pulmocide Ltd0 sites56 target enrollmentJuly 14, 2017

ConditionsHuman Respiratory Syncytial Virus (RSV)MedDRA version: 20.0 Level: LLT Classification code 10070358 Term: Human respiratory syncytial virus test positive System Organ Class: 100000109842 Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Respiratory Syncytial Virus (RSV)
Sponsor: Pulmocide Ltd
Enrollment: 56
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 14, 2017

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Pulmocide Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Subject must be male or female, aged between 18 and 55 years inclusive (at the time of consent) who fit one of the following criteria
•Women of childbearing potential who have a documented menstrual period within 28 days prior to first dose.
•Women of non\-childbearing potential defined as being amenorrhoeic for \>12 months with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms).
•Men who are willing and able to use one of the contraception methods described in the protocol, from the time of the date of Viral Challenge, until 90 days after receipt of the final dose of study medication.
•2\. Sero\-suitable to the challenge virus
•3\. In good health with no history of major medical conditions that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests and determined by the Investigator at a screening evaluation. The following conditions are deemed acceptable:
•Subjects with a history of rhinitis, currently inactive (within the last 30 days and not required nasal corticosteroids in this time) or with ongoing mild rhinitis may be included at the PI’s discretion
•Subjects with clinically mild atopic eczema/atopic dermatitis and clinically mild psoriasis may be included at the Investigator's discretion (e.g., use of low/mild potency regular topical steroids is acceptable. Eczema in the cubital fossa and/or use of medium to high potency dermal corticosteroids are exclusions)
•Subjects with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test (TFT) can be included at the discretion of the PI
•Subjects reporting physician diagnosed migraine can be included as long as there are no associated neurological symptoms such as hemiplegia or visual loss

Exclusion Criteria

•1\. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge
•2\. Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalised due to epistaxis on any previous occasion
•3\. Any nasal or sinus surgery within six months of inoculation
•4\. Subjects who have smoked \= 10 pack years at any time
•5\. Subjects who have smoked \< 10 pack years at any time if in the month prior to admission to the Quarantine Unit they have used tobacco in any form or other nicotine\-containing products in any form or e\-cigarettes
•6\. History or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, renal, neurological, psychiatric illness
•Psychiatric illness includes subjects with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis
•Subjects with a history of depression of any severity within the last 2 years will be excluded if the PHQ\-9 score is \= 4
•Subjects with history of anxiety\-related symptoms of any severity within the last two years will be excluded if the GAD\-7 score is \= 4
•7\. Other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations. The following apply: